Summary
Overview
Work History
Education
Skills
Accomplishments
Roles And Responsibilities
Projectshandled
Auditsexposure
Personal Information
Computertechnicalknowledge
Namesignature
Languages
Disclaimer
Timeline
Generic

Tarakaram Pappu

Computer System Validation Specialist
Hyderabad

Summary

Total 12+ years’ experience in Quality Operations for Pharmaceutical industries in which 08+ years for Computer system validation (CSV) compliance and 04+ years for Shop floor compliance.

Overview

13
13
years of professional experience
2
2
years of post-secondary education

Work History

CSV Lead

Tata consultancy services limited
7 2023 - Current
  • Presented project reports to stakeholders on project status, risks, achievements, and recommendations for future actions as part of Computer System validations compliance.
  • Maintained compliance with internal SOPs and external regulations and brought compliance issues to attention of management.
  • Provided mentorship and guidance to junior team members in developing their skills and expertise in the domain

QA Senior-Executive (CSV & Audit compliance)

M/S Laurus labs limited, Unit-02
12.2021 - 06.2023
  • Championed quality assurance procedures, maintaining consistency across all projects as part of Computer System Validation.
  • Improved data integrity by implementing rigorous validation processes and quality assurance measures.

QA Senior-Executive (CSV & Audit compliance)

M/S Aurobindo Pharmaceuticals Ltd, Unit 15
02.2015 - 12.2021
  • Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.

In-process QA

M/S Dr.Reddys laboratories Ltd
03.2013 - 02.2015

Performing regular activities as part of In-process Quality Assurance checks.

IPQA

Espi Industries & Chemical Pvt Ltd
09.2011 - 03.2013

Performing regular activities as part of In-process Quality Assurance checks.

  • Streamlined documentation processes, resulting in improved efficiency and accuracy of recordkeeping

Education

Master of Science - Pharmaceutical Sciences

JNTU Hyderabad
Hyderabad
07.2013 - 01.2015

Skills

GAMP Categorization

Accomplishments

  • Received Best performer of the month & year in Aurobindo pharma ltd.
  • Successfully completion of new block qualifications with in the time line for Laurus & Aurobindo pharma ltd.
  • Received recognition for completion of PMTS project implementation in Aurobindo pharma ltd., with in the time line.
  • Successful completion of Data Migration Project in TCS for client.

Roles And Responsibilities

  • Responsible to perform GxP assessment, GAMP categorizations and identification of suitable Validation strategies for Applications or Computerized systems.
  • Qualifying & validation of the Applications as per V-Model approach & Agile methodologies. Experience in the development, implementation and lifecycle management of computerized systems in regulated environments
  • Responsible for Prepare and review of all levels of CSV validation documents as per US FDA 21 CFR Part 11 & EU Annex-11 guidelines.
  • Review of User stories, URS, Design, functional specifications & technical documents.
  • Review and Approving of validation documents like Validation plan, IQ and OQ Protocols, Requirement Traceability Matrix, and Validation Report.
  • Review the IQ, OQ and PQ test scripts/ Protocols with annexures to verify that key aspects of the hardware and software installation adhere to pre-approved specifications in Quality/ Production Environments.
  • Review & approve the periodic review reports for the GxP computerized systems and the associated gaps within CAPA Management System, Audit trails & backup schedules of the GxP computerized systems.
  • Preparation and review of System Retirement & Data Migration plans.
  • Coordinating with vendor for timely completion of Validation deliverables.
  • Preparation and Periodic revision of VMP and validation related SOPs.
  • Perform the Vendor or Supplier assessment as part of qualification..
  • Change control management: Evaluation and approval of changes with impact assessment from quality and regulatory perspective.
  • Conducting investigations to identify the possible root cause for any deviations from written procedures. Assessing the impact of the deviation and Identifying Corrective and Preventive actions to prevent recurrence and occurrence of the deviation.
  • Performing Risk assessment studies for the processes and systems and preparing plans for mitigating risks with high severity by using Risk management tools.
  • Compilation of investigation reports and related documents for their closure with prescribed documentation.
  • Establishing procedures to mitigate the gaps identified during systemic assessments, regulatory inspections, internal audits and customer audits.
  • Having knowledge on SDLC (Software development lifecycle) models. Good understanding in system application management (ITIL, ITSM, etc)

Projectshandled

  • RPA (Blueprism)
  • MES (eDHR)
  • PMTS (Pharma material tracking system)
  • DSRS (Document storage & retrieval system)
  • BMS (Building management system) & AMS (Artwork management system)
  • QMS (Quality management sytem)
  • LIMS, SAP & ERP
  • Standalone Manufacturing, Packing Equipment’s & Analytical instruments software Qualification.

Auditsexposure

MHRA, US-FDA,WHO, ANVISA & ROW

Personal Information

  • Father's Name: Pappu Ganeswararao
  • Date of Birth: 02/16/90
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married
  • Religion: Hindu

Computertechnicalknowledge

  • Jira & HPALM
  • SAP & ERP
  • E-QMS & eDMS
  • LIMS
  • PMTS
  • LMS & DMS
  • Service now

Namesignature

P.Tarakaram

Languages

Telugu, Oriya, Hindi & English

Disclaimer

I hereby declare all above information furnished is true and correct to the best of my knowledge.

Timeline

QA Senior-Executive (CSV & Audit compliance)

M/S Laurus labs limited, Unit-02
12.2021 - 06.2023

QA Senior-Executive (CSV & Audit compliance)

M/S Aurobindo Pharmaceuticals Ltd, Unit 15
02.2015 - 12.2021

Master of Science - Pharmaceutical Sciences

JNTU Hyderabad
07.2013 - 01.2015

In-process QA

M/S Dr.Reddys laboratories Ltd
03.2013 - 02.2015

IPQA

Espi Industries & Chemical Pvt Ltd
09.2011 - 03.2013

CSV Lead

Tata consultancy services limited
7 2023 - Current
Tarakaram PappuComputer System Validation Specialist